The present invention relates to the use of racemic 6-acetyl-7-[5-(4-acetyl-3-hydroxy-2-propylphenoxy)pentyloxy]-3,4-dihydro-2 H-1-benzopyran-2-carboxylic acid, or a salt, lower alkyl ester or enantiomer thereof, as an anti-inflammatory agent in the therapeutic treatment of inflammatory bowel disease and other leukotriene-mediated mucosal inflammation of the intestines, by various routes of administration.
Inflammatory bowel disease is a term often used to refer to inflammatory conditions of the bowel or other portions of the intestinal tract which have as a common feature a chronic or acute inflammation of the gastrointestinal mucosa. Various forms are generally understood to include Crohn's disease of the ileum and colon, ulcerative colitis, neonatal necrotizing enterocolitis and food allergy. They are characterized histopathologically by ulceration, pseudomembranes, radiologically visible lesions, edema and the build-up of inflammatory cells, and symptoms involve diarrhea, abdominal pain, weight loss and hypoproteinemia. Descriptions in the literature include Northfield, Drugs 14: 198-206 (1977); Blaker, et al. Eur. J. Pediatr. 139: 162-164 (1982); Singleton, The Gastroenterology Annual, pp. 268-310 (1983); Saco, et al. J. Amer. Acad. Dermatol. 4: 619-629 (1981); Prantera, et al. Ital. J. Gastroenterol. 13: 24-27 (1981); Sales, et al. Arch. Int. Med. 143: 294-299 (1983), and Ament, Inflammatory Bowel Diseases, Martinus Nijhoff Publ., Boston, Mass., pp. 254-268 (1982). Less frequent but also possible are mucosal inflammation of other sections of the gastrointestinal tract, such as duodenitis, jejunitis and proctitis.
Drugs useful in the treatment of such conditions include sulfasalazine and others that deliver 5-aminosalicylate to the bowel, corticosteroids, metronidazole and cholestyramine, as described by Sack and Peppercorn in Pharmacotherapy 3: 158-176 (1983).